FDA Product Code SAL: Device, Automated Cell Locating, Bone Marrow
An Automated Cell-locating Device For Bone Marrow Aspirate Is An In Vitro Diagnostic Device Intended For Prescription Use That Automatically Locates And Presents Images Of Hematopoietic Cells On A Bone Marrow Aspirate Smear Obtained From Patients Being Evaluated For Hematologic Diseases. The Device Assists Operators To Identify And Classify Each Cell According To Type.
Leading manufacturers include Scopio Labs , Ltd..
FDA 510(k) Cleared Device, Automated Cell Locating, Bone Marrow Devices (Product Code SAL)
About Product Code SAL - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SAL since 2024, with 0 receiving FDA clearance (average review time: 329 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
SAL devices are reviewed by the Hematology panel. Browse all Hematology devices →